Status:
COMPLETED
62% & 15% Ethanol in Emollient Gel as Topical Male Microbicides
Lead Sponsor:
University of Washington
Collaborating Sponsors:
National Institute of Allergy and Infectious Diseases (NIAID)
Conditions:
Sexually Transmitted Infections
Eligibility:
MALE
18+ years
Phase:
PHASE1
Brief Summary
The purpose of this study is to look at the safety and acceptance of using a microbicide (product that kills germs) gel to clean the genital area. Microbicide gel is used by hospital workers to clean ...
Detailed Description
In Kenya, the HIV/AIDS epidemic has significantly increased adult and child mortality. Current prevention options, including the ABC model (Abstinence, Be faithful and correct and consistent Condom us...
Eligibility Criteria
Inclusion
- Male
- 18 years or older
- Working in the fishing industry for at least 3 months and living and working along the shores of Lake Victoria within a 70km radius of Kisumu, Kenya
- Uncircumcised
- Sexually active (have had sex in the last 2 weeks)
- Commercial or transactional sex during the past month
- Inconsistent condom use (less than 25% of all sex acts)
- Ability \& willing to attend the clinic for a eight week period
Exclusion
- STI diagnosis on clinical examination
- History of or evidence of dermatological inflammation (e.g. balanitis, phimosis, swelling of prepuce, warts on penis) upon clinical examination
- History of genital ulcer disease, penile trauma, dyspareunia (pain during sex), foreskin tears
- Congenital abnormalities: hypospadias, epispadias
- HIV, HSV-2 and syphilis-seropositive
- LE positive
- History of allergic reaction to alcohol products.
- Preference for oral sex
- Participating in HIV/HSV-2 or participated male circumcision studies based in Kisumu
- Investigator discretion
Key Trial Info
Start Date :
November 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2008
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00469547
Start Date
November 1 2007
End Date
December 1 2008
Last Update
April 30 2009
Active Locations (1)
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1
Kenya Medical Research Institute
Kisumu, Kenya